MAUDE Adverse Event Report: VIVEVE, INC. GENEVEVE ELECTROSURGICAL CUTTING AND COAGULATION DEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Burning Sensation (2146); Numbness (2415)

Event Date 03/23/2017

Event Type  Injury  

Event Description

I received the geneveve treatment which is a rf device vaginal rejuvenation treatment made by viveve, inc. Within a few days of the treatment, my vagina felt numb and still does. It also has a constant burning sensation near the internal area right past my introitus. It's been 16 months and i no longer enjoy vaginal intercourse because of the numb sensation and constant burning feeling. They promote it for vaginal rejuvenation, laxity, dryness and desire.

• Brand Name: GENEVEVE
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE
• Manufacturer (Section D): VIVEVE, INC.
• MDR Report Key: 7742801
• Report Number: MW5078794
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

• Patient Age: 53 YR
• Patient Weight: 52
• Patient Outcome(s): Other